- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04110392
Effect of Consumption of Chaya on Lipid Concentration and Antioxidant Status of Patients With Dyslipidemia
Effect of Consumption of a Beverage of Chaya (Cnidoscolus Chayamansa) on Lipid Concentration, Lipid Peroxidation and Antioxidant Status of Patients With Dyslipidemia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The protocol will be carried out in the Hospital Regional de Alta Especialidad de la Península de Yucatán (HRAEPY). It is quasi-experimental and it was proposed before and after study, the study will be consisting in 6 subsequent visits and a last visit to deliver results to the participant.
In the pre-visit, the subjects will be evaluated to determine if they meet the inclusion criteria. They will be explained what the study consists of, the characteristics, the risks and the expected benefits after the intervention, they will be asked to read the consent letter, doubts will be clarified about it and if the participant agrees to be in the study the signature will be made of the consent letter.
At the beginning and end will be taken two blood samples of 5 mL to each participant. One will be to obtain the serum and measure cholesterol-HDL, cholesterol-LDL, triglycerides, total cholesterol, glucose, antioxidant activity, malondialdehyde (MDA) and C-reactive protein. The second sample will be to the extraction of peripheral leukocyte blood mononuclear cells and determine the gene expression of antioxidants enzymes superoxide dismutase (SOD) and catalase (CAT). Blood pressure will be measured with a digital baumanometer while the participant will remain seated with the right arm uncovered. The measurement will be carried out 6 times, in intervals of 3 minutes. The first measurement will be discarded and the average of the remaining measurements will be reported. In the visits will bring to each participant an attachment to reported intake of the beverage. During the following ones it will always be questioned if there is any problem with the drinking the beverage of Chaya.
At the end of the study, participants will be given the document with their results and will be given recommendations for weight control, dietary recommendations to improve lipid concentrations. They will refer to their doctor for follow-up with their laboratory results for their control.
Description of the intervention
Chaya Water Beverage of Chaya will be prepared as follows: 40 g of Chaya leaves will be treated with a commercial brand disinfectant following the manufacturer's instructions for use, then added 1L of purified water and mixed in blender. Finally, 500 mL of it will be placed in bottles. Participants will be instructed to consume 1 bottle per day for 6 weeks. 7 bottles will be delivered at each visit, which will be consumed during the week; participants will be instructed to keep the water refrigerated until it is consumed.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Yucatán
-
Mérida, Yucatán, Mexico, 97130
- Hospital Regional de Alta Especialidad de la Península de Yucatán
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male and female.
- Adults between 20 and 60 years.
- BMI ≥ 20 and ≤ 39.9 kg / m².
- Mestizo Mexicans: parents and grandparents born in Mexico.
- Patients diagnosed with dyslipidemia.
- Dyslipidemia will be defined by any? alteration in the concentrations of the following lipoproteins: LDL cholesterol> 130mg/dL or total cholesterol> 200 mg/dL or triglycerides> 150 mg/dL
- Patients should know how to read and write.
- Signature of informed consent.
Exclusion Criteria:
- Patients with any type of diabetes previously diagnosed
- Patients with acquired diseases that produce secondary obesity and diabetes.
- Patients who have suffered a cardiovascular event.
- Weight loss> 3 kg in the last 3 months.
- Catabolic diseases such as cancer and acquired immunodeficiency syndrome.
- Positive smoking.
Drug treatment:
- Antihypertensive drugs (thiacyclic, loop or potassium-sparing diuretics, angiotensin II receptor blockers, alpha blockers, calcium antagonists, beta blockers).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Chaya (Cnidoscolus chayamansa)
Chaya Water Beverage of Chaya will be prepared as follows: 40 g of Chaya leaves will be treated with a commercial brand disinfectant following the manufacturer's instructions for use, then added 1L of purified water and mixed in blender.
Finally, 500 mL of it will be placed in bottles.
Participants will be instructed to consume 1 bottle per day for 6 weeks.
7 bottles will be delivered at each visit, which will be consumed during the week; participants will be instructed to keep the water refrigerated until it is consumed.
|
Chaya Water Beverage of Chaya will be prepared as follows: 40 g of Chaya leaves will be treated with a commercial brand disinfectant following the manufacturer's instructions for use, then added 1L of purified water and mixed in blender.
Finally, 500 mL of it will be placed in bottles.
Participants will be instructed to consume 1 bottle per day for 6 weeks.
7 bottles will be delivered at each visit, which will be consumed during the week; participants will be instructed to keep the water refrigerated until it is consumed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline triglycerides concentration at 6 weeks of intervention
Time Frame: At the beginning of the study and after 6 weeks of intervention
|
Serum triglyceride measurement by the method of colorimetry enzymatic
|
At the beginning of the study and after 6 weeks of intervention
|
Change from baseline Lipoproteins concentration at 6 weeks of intervention
Time Frame: At the beginning of the study and after 6 weeks of intervention
|
Total cholesterol, LDL and HDL measurement by the method of colorimetry enzymatic
|
At the beginning of the study and after 6 weeks of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline blood gene expression of superoxide dismutase at 6 weeks of intervention
Time Frame: At the beginning of the study and after 6 weeks of intervention
|
Gene expression of superoxide dismutase measurement by qPCR method
|
At the beginning of the study and after 6 weeks of intervention
|
Change from baseline blood gene expression of catalase at 6 weeks of intervention
Time Frame: At the beginning of the study and after 6 weeks of intervention
|
Blood gene expression of catalase measurement by quantitative polymerase chain reaction (qPCR) method
|
At the beginning of the study and after 6 weeks of intervention
|
Change from baseline serum antioxidant activity at 6 weeks of intervention
Time Frame: At the beginning of the study and after 6 weeks of intervention
|
Serum antioxidant activity measurement by spectrophotometric method
|
At the beginning of the study and after 6 weeks of intervention
|
Change from baseline serum C-Reactive Protein at 6 weeks of intervention
Time Frame: At the beginning of the study and after 6 weeks of intervention
|
Serum C-Reactive Protein measurement by the method of colorimetry enzymatic
|
At the beginning of the study and after 6 weeks of intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Azalia Avila Nava, PhD, Hospital Regional de Alta Especialidad de la Península de Yucatán
Publications and helpful links
General Publications
- Garcia-Rodriguez RV, Gutierrez-Rebolledo GA, Mendez-Bolaina E, Sanchez-Medina A, Maldonado-Saavedra O, Dominguez-Ortiz MA, Vazquez-Hernandez M, Munoz-Muniz OD, Cruz-Sanchez JS. Cnidoscolus chayamansa Mc Vaugh, an important antioxidant, anti-inflammatory and cardioprotective plant used in Mexico. J Ethnopharmacol. 2014 Feb 3;151(2):937-43. doi: 10.1016/j.jep.2013.12.004. Epub 2013 Dec 11.
- Loarca-Pina G, Mendoza S, Ramos-Gomez M, Reynoso R. Antioxidant, antimutagenic, and antidiabetic activities of edible leaves from Cnidoscolus chayamansa Mc. Vaugh. J Food Sci. 2010 Mar;75(2):H68-72. doi: 10.1111/j.1750-3841.2009.01505.x.
- Kuti JO, Kuti HO. Proximate composition and mineral content of two edible species of Cnidoscolus (tree spinach). Plant Foods Hum Nutr. 1999;53(4):275-83. doi: 10.1023/a:1008081501857.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-030
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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